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Impact of Chronic Exposure to Radiofrequency Electromagnetic Fields on Neurophysiological Development in the Preterm Neonate (NeuroPrem-RF)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Preterm Infant Exposure to Radiofrequency | Other: Parental questionnaire Other: Daily continuous recording of radiofrequency exposure levels Other: Follow-up of daily infants environmental and clinical parameters Other: Nocturnal polysomnography Diagnostic Test: cerebral hemodynamics Diagnostic Test: activity of the autonomic nervous system | Not Applicable |
Preterm infants are potentially exposed to chronic, low levels of electromagnetic fields, especially radiofrequencies, while hospitalized in neonatal intensive care units. Moreover, they may be particularly vulnerable due to increased penetration of radiofrequency waves into the brain during a crucial period of neurodevelopment. This study will aim at evaluating the influence of radiofrequency electromagnetic fields exposure on the neurophysiological development in preterm neonates.
The first part of this study will be devoted to the measurement of environmental electromagnetic fields in order to map their distribution in the paediatric department. From birth and during 6 weeks, the investigators will perform, for each child, a continuous measurement of radiofrequencies at the incubator level. Infants' clinical data (medical history, nutrition, morphology...) and the evolution of the thermal environment in incubators (air and body temperatures) will also be continually monitored. At 3 and 6 weeks of life, the investigators will investigate sleep (EEG, EOG), cerebral hemodynamics (near-infrared spectroscopy), autonomic nervous system activity (ECG, heart rate variability) and various cardiorespiratory parameters (SpO2, apnoea, bradycardia) thanks to a night-time polysomnography.
The impact of radiofrequency electromagnetic fields will be evaluated by analyses of the relationship between exposure levels and the various parameters extracted from the neurophysiological investigation phase.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Screening |
| Official Title: | Impact of Chronic Exposure to Radiofrequency Electromagnetic Fields on Neurophysiological Development in the Preterm Neonate |
| Estimated Study Start Date : | April 2019 |
| Estimated Primary Completion Date : | October 2020 |
| Estimated Study Completion Date : | December 2022 |
- total sleep time in hours [ Time Frame: from birth to 6 weeks of life ]Sleep Structure will be determined by measuring total sleep time, absolute and relative durations of sleep states and sleep state change frequency.
- absolute durations of sleep states in hours [ Time Frame: from birth to 6 weeks of life ]Sleep Structure will be determined by measuring total sleep time, absolute and relative durations of sleep states and sleep state change frequency.
- relative durations of sleep states in hours [ Time Frame: from birth to 6 weeks of life ]Sleep Structure will be determined by measuring total sleep time, absolute and relative durations of sleep states and sleep state change frequency.
- sleep state change frequency [ Time Frame: from birth to 6 weeks of life ]Sleep Structure will be determined by measuring total sleep time, absolute and relative durations of sleep states and sleep state change frequency.
- Cerebral hemodynamics [ Time Frame: from birth to 6 weeks of life ]Cerebral hemodynamics will be determined by measuring regional cerebral oxygen saturation
- Autonomic nervous system activity [ Time Frame: from birth to 6 weeks of life ]Autonomic nervous system activity will be determined by measuring means of a heart rate variability
- apnea frequency [ Time Frame: from birth to 6 weeks of life ]cardiorespiratory parameters (apnea, bradycardia, desaturation) will be determined
- bradycardia frequency [ Time Frame: from birth to 6 weeks of life ]cardiorespiratory parameters (apnea, bradycardia, desaturation) will be determined
- desaturation frequency [ Time Frame: from birth to 6 weeks of life ]cardiorespiratory parameters (apnea, bradycardia, desaturation) will be determined
- Evolution of the anthropomorphic characteristics of the subjects [ Time Frame: from birth to 6 weeks of life ]anthropomorphic characteristics of the subjects are height and weight. Weight and height will be combined to report BMI in kg/m^2.
| Tracking Information | ||||||||||
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| First Submitted Date ICMJE | April 16, 2019 | |||||||||
| First Posted Date ICMJE | April 26, 2019 | |||||||||
| Last Update Posted Date | April 26, 2019 | |||||||||
| Estimated Study Start Date ICMJE | April 2019 | |||||||||
| Estimated Primary Completion Date | October 2020 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | No Changes Posted | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Impact of Chronic Exposure to Radiofrequency Electromagnetic Fields on Neurophysiological Development in the Preterm Neonate | |||||||||
| Official Title ICMJE | Impact of Chronic Exposure to Radiofrequency Electromagnetic Fields on Neurophysiological Development in the Preterm Neonate | |||||||||
| Brief Summary | The massive use of highly technological devices in Neonatal Intensive Care Units may expose preterm neonates to electromagnetic fields, especially radiofrequencies, at low doses but continuously and chronically. Strikingly, the effect of long-term exposure to radiofrequencies on the neurophysiological development of preterm neonates has never been studied so far. The only studies on the impact of chronic exposure to radiofrequencies have been conducted in animals or adult humans, whereas preterm infants may be particularly vulnerable due to increased penetration of radiofrequency waves into the brain during a crucial period of neurodevelopment. The present project will aim at 1) quantifying individual levels of chronic exposure (during 6 weeks) to which preterm neonates are subjected during their stay in the Neonatal Intensive Care Unit, 2) following the evolution of the thermal environment and of the clinical parameters of the neonates after birth, 3) identifying potential alterations of neurophysiological activity (sleep, cerebral hemodynamics, autonomic nervous activity) which will be correlated to actual levels of chronic RF-EMF (radiofrequency electromagnetic fields) exposure. | |||||||||
| Detailed Description |
Preterm infants are potentially exposed to chronic, low levels of electromagnetic fields, especially radiofrequencies, while hospitalized in neonatal intensive care units. Moreover, they may be particularly vulnerable due to increased penetration of radiofrequency waves into the brain during a crucial period of neurodevelopment. This study will aim at evaluating the influence of radiofrequency electromagnetic fields exposure on the neurophysiological development in preterm neonates. The first part of this study will be devoted to the measurement of environmental electromagnetic fields in order to map their distribution in the paediatric department. From birth and during 6 weeks, the investigators will perform, for each child, a continuous measurement of radiofrequencies at the incubator level. Infants' clinical data (medical history, nutrition, morphology...) and the evolution of the thermal environment in incubators (air and body temperatures) will also be continually monitored. At 3 and 6 weeks of life, the investigators will investigate sleep (EEG, EOG), cerebral hemodynamics (near-infrared spectroscopy), autonomic nervous system activity (ECG, heart rate variability) and various cardiorespiratory parameters (SpO2, apnoea, bradycardia) thanks to a night-time polysomnography. The impact of radiofrequency electromagnetic fields will be evaluated by analyses of the relationship between exposure levels and the various parameters extracted from the neurophysiological investigation phase. |
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| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Not Applicable | |||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Screening |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE | Not Provided | |||||||||
| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Not yet recruiting | |||||||||
| Estimated Enrollment ICMJE |
50 | |||||||||
| Original Estimated Enrollment ICMJE | Same as current | |||||||||
| Estimated Study Completion Date ICMJE | December 2022 | |||||||||
| Estimated Primary Completion Date | October 2020 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | up to 1 Day (Child) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Not Provided | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT03928457 | |||||||||
| Other Study ID Numbers ICMJE | PI2018_843_0033 | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Centre Hospitalier Universitaire, Amiens | |||||||||
| Study Sponsor ICMJE | Centre Hospitalier Universitaire, Amiens | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
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| PRS Account | Centre Hospitalier Universitaire, Amiens | |||||||||
| Verification Date | April 2019 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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